Synthetic Blood International Inc. on Monday said it secured a three-year, $20 million equity line that will help it finance development of its lead product, Oxycyte, a synthetic blood substitute.
The equity line is through Dutchess Private Equities Fund in Boston.
Synthetic Blood (SYBD), of Costa Mesa, Calif., said it is pleased with the financing because it comes on the heels of its meeting with the FDA May 24 at which the they discussed remaining laboratory and animal studies that will be required for the investigational new drug application and commencement of clinical trials for Oxycyte.
Based on fluorocarbon technology, the company anticipates Oxycyte would be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute in organ preservation.
Robert Nicora, Synthetic Blood's president, said in a prepared statement, "Financing of this magnitude will take us well into Phase III clinical trials with Oxycyte. When coupled with the positive outcome of our recent meeting with the FDA and the ability to forecast the start of late-stage clinical testing of Oxycyte within two years, we believe that the gap between SYBD and our competitors is significantly closing. These developments substantially lower the risks associated with SYBD becoming a serious player in the race to introduce a blood substitute."
The developments have enabled the company to project milestones for Oxycyte. In August, the company expects to complete primate studies, and then it plans to file an IND in the fourth quarter. Phase I trials are expected to start in January, and Phase II trials should begin in the second quarter of next year. Finally, Phase III trials are expected to start in the first half of 2004, the company said.
Oxycyte did not produce pulmonary hyperinflation in rabbit studies, the company said in a statement released last August.
The company also is developing a product called Fluorovent, a liquid ventilation product that may be useful in treating respiratory disorders in adults and children. As with Oxycyte, Fluorovent is based on Synthetic Blood's fluorocarbon technology.
The abstract on Oxycyte has been accepted for presentation as a poster at the 4th International Meeting on Current Issues in Blood Substitute Research in Stockholm, Sweden, on Thursday, the company said.
The company's stock (OTCBB:SYBD) gained 5 cents Monday to close at 35 cents.